NCT05326620

Brief Summary

PRO-RCC is a nationwide long-term cohort for the collection of real-world clinical data, patient reported outcome measures (PROMs) and patient reported experience measures (PREMs) that provides an infrastructure for observational research and (randomized) interventional studies with the TwiCs (Trial within cohorts) design.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

27 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2023Jan 2030

First Submitted

Initial submission to the registry

March 17, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

January 19, 2023

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

7 years

First QC Date

March 17, 2022

Last Update Submit

June 3, 2025

Conditions

Renal CancerRenal Cell CarcinomaRenal Cell Cancer Metastatic

Outcome Measures

Primary Outcomes (3)

  • survival

    overall survival

    5 years

  • progression

    local or distant recurrence

    5 years

  • patient reported outcome measures (PROMS)

    measured with the EORTC QLQ-C30 questionnaire, every three months in the first year, then yearly up to five years.

    5 years

Secondary Outcomes (1)

  • Patient reported outcomes of adverse events

    2 years

Study Arms (2)

localized RCC

all patients with localized RCC

metastatic RCC

all patients with metastatic RCC, synchronous or metachronous

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients with newly diagnosed (m)RCC can be included, or with synchronous metastasized RCC

You may qualify if:

  • newly diagnosed patients with RCC or synchronous metastatic RCC
  • metachronous metastasized RCC
  • age \>18 years
  • capable of understanding Dutch language

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Amsterdam UMC locatie VUMC

Amsterdam, North Holland, Netherlands

RECRUITING

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

RECRUITING

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

RECRUITING

Meander Medisch Centrum

Amersfoort, Netherlands

RECRUITING

Gelre ziekenhuis

Apeldoorn, Netherlands

RECRUITING

Rijnstate

Arnhem, Netherlands

RECRUITING

Amphia Ziekenhuis

Breda, Netherlands

RECRUITING

Deventer Ziekenhuis

Deventer, Netherlands

RECRUITING

Albert Schweitzer

Dordrecht, Netherlands

RECRUITING

Catharina ziekenhuis

Eindhoven, Netherlands

RECRUITING

Maxima MC

Eindhoven, Netherlands

RECRUITING

Treant

Emmen, Netherlands

RECRUITING

UMCG

Groningen, Netherlands

RECRUITING

Spaarne Gasthuis

Haarlem, Netherlands

RECRUITING

Tergooi MC

Hilversum, Netherlands

RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

RECRUITING

Maastricht UMC

Maastricht, Netherlands

RECRUITING

St Antonius Ziekenhuis

Nieuwegein, Netherlands

RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

RECRUITING

Bravis ziekenhuis

Roosendaal, Netherlands

RECRUITING

Erasmus MC

Rotterdam, Netherlands

RECRUITING

Maasstad ziekenhuis

Rotterdam, Netherlands

RECRUITING

St. Franciscus ziekenhuis

Rotterdam, Netherlands

RECRUITING

Haaglanden Medisch Centrum

The Hague, Netherlands

RECRUITING

UMC Utrecht

Utrecht, Netherlands

RECRUITING

Viecuri

Venray, Netherlands

RECRUITING

Isala

Zwolle, Netherlands

RECRUITING

Related Publications (1)

  • Yildirim H, Widdershoven CV, Aarts MJ, Bex A, Bloemendal HJ, Bochove-Overgaauw DM, Hamberg P, Herbschleb KH, van der Hulle T, Lagerveld BW, van Oijen MG, Oosting SF, van Thienen JV, van der Veldt AA, Westgeest HM, Zeijdner EE, Aben KK, van den Hurk C, Zondervan PJ, Bins AD. The PRO-RCC study: a long-term PROspective Renal Cell Carcinoma cohort in the Netherlands, providing an infrastructure for 'Trial within Cohorts' study designs. BMC Cancer. 2023 Jul 11;23(1):648. doi: 10.1186/s12885-023-11094-9.

    PMID: 37434119DERIVED

Related Links

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Adriaan Bins, MD, PhD

    Amsterdam UMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilin Yildirim, MD

CONTACT

0031643202583h.yildirim@iknl.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2022

First Posted

April 13, 2022

Study Start

January 19, 2023

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

NL(27)